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- Tasks: Lead and oversee clinical trial sites, ensuring compliance and safety.
- Company: Join a dynamic team in the biotech/pharmaceutical industry focused on innovative research.
- Benefits: Enjoy flexible working options, professional development opportunities, and a collaborative culture.
- Why this job: Make a real impact in clinical research while developing your skills in a fast-paced environment.
- Qualifications: 4+ years of CRA experience; a degree in science or healthcare is preferred.
- Other info: Opportunity to work with cutting-edge technology and contribute to life-changing studies.
The predicted salary is between 36000 - 60000 £ per year.
The Lead Clinical Research Associate is a critical core team member responsible for the oversight of a defined set of clinical trial sites within a region. They oversee clinical trial sites to ensure compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. They serve as the primary point of contact for the site and act as the primary liaison between the site and my client.
The CRA will conduct site visits, oversee essential document collection and review, and prepare trip reports to summarise monitoring activities.
Essential Functions of the job:- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
- Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies site processes to obtain informed consent have been adequately performed and documents for each subject.
- Assesses site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan.
- Performs Source Data Review/Source Data Verification for assigned clinical trial sites.
- Reviews investigational product inventory, reconciliation and storage at trial sites, ensuring GCP guidelines are followed.
- Reviews the Investigator Site File for accuracy and completeness.
- Provides site and regional metrics into trackers to support project-level report generation.
- Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
- Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Minimum of 4 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity.
- B.S., scientific or healthcare degree preferred.
- Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
- Excellent organisational and communication skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines.
- Proficient with Microsoft Office Suite, Project Management tools.
- Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.
Lead Clinical Research Associate employer: JR United Kingdom
Contact Detail:
JR United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Clinical Research Associate
✨Tip Number 1
Network with professionals in the clinical research field. Attend industry conferences, webinars, or local meetups to connect with current Lead Clinical Research Associates and learn about their experiences. This can provide you with valuable insights and potentially lead to job referrals.
✨Tip Number 2
Familiarise yourself with the latest ICH GCP guidelines and any recent changes in regulations. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare for potential interview questions by practising how you would handle specific scenarios related to site management and monitoring. Think of examples from your past experience that showcase your problem-solving skills and ability to ensure compliance.
✨Tip Number 4
Showcase your organisational and communication skills during networking events or interviews. Be ready to discuss how you've successfully managed multiple tasks in a fast-paced environment, as this is crucial for the role of a Lead Clinical Research Associate.
We think you need these skills to ace Lead Clinical Research Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical monitoring and research. Emphasise your understanding of ICH GCP guidelines and any specific achievements in previous roles that align with the responsibilities of a Lead Clinical Research Associate.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your ability to manage multiple tasks effectively. Mention specific experiences where you ensured compliance with regulatory requirements and how you contributed to successful trial outcomes.
Highlight Key Skills: In your application, clearly outline your organisational and communication skills. Provide examples of how you've worked collaboratively in fast-paced environments and managed site-level activities to meet project objectives.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for any grammatical errors or typos, as attention to detail is crucial in clinical research roles. A polished application reflects your professionalism and commitment.
How to prepare for a job interview at JR United Kingdom
✨Know Your Clinical Trial Regulations
Make sure you have a solid understanding of ICH GCP guidelines and local regulations. Be prepared to discuss how you've applied these in your previous roles, as this will demonstrate your expertise and readiness for the position.
✨Showcase Your Organisational Skills
As a Lead Clinical Research Associate, you'll need to manage multiple tasks and sites. Bring examples of how you've successfully organised your workload in the past, and be ready to explain your strategies for prioritising tasks.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and judgement. Think of specific situations where you had to identify issues affecting subject safety or data integrity, and be ready to discuss how you handled them.
✨Demonstrate Your Communication Skills
Effective communication is key in this role. Prepare to discuss how you've liaised with site staff and project teams in the past, and consider sharing examples of how you ensured compliance and facilitated training.
